Manufacturing Quality Engineer

Position: Engineering – Sr Engr

Contract: 12+ months with possible extension

Role Overview:

• Own CAPA records end-to-end, including investigation, root cause, corrective actions, effectiveness checks, and closure.
• Lead RCA using 5 Whys, Fishbone, Fault Tree Analysis, 8D, and DMAIC .
• Ensure CAPA and Quality System documentation meets ISO 13485 and FDA 21 CFR 820 requirements.
• Partner with Manufacturing, Operations, R&D, and Supplier Quality teams to implement corrective actions.
• Perform data trending/statistical analysis to verify CAPA effectiveness and support audit readiness.
• Maintain accurate records in eQMS systems such as TrackWise, MasterControl, or equivalent.

Key Requirements:

• 5–7+ years of relevant Quality Engineering experience.
• Bachelor's degree in Engineering preferred/required based on client requirements.
• Strong CAPA, NCR/NCMR, RCA, and technical documentation experience.
• Medical device or regulated manufacturing experience.
• Experience with ISO 13485 and FDA 21 CFR 820.